Medical retrieval systems and related methods

ABSTRACT

A medical device may include a stabilizer configured to be coupled to a port of an insertion device. The medical device may further include a shaft configured for telescopic translation within the stabilizer and a grip coupled to the shaft. Further, the medical device may include an actuator coupled to the grip. The actuator may be axially moveable relative to the grip so as to selectively actuate a distal assembly of the medical device.

CROSS-REFERENCE TO RELATED APPLICATIONS

The application claims the benefit of priority from U.S. ProvisionalApplication No. 62/056,303, filed on Sep. 26, 2014, the entirety ofwhich is incorporated herein by reference.

TECHNICAL FIELD

Various aspects of the present disclosure relate generally to retrievaldevices and related systems and methods. More specifically, the presentdisclosure relates to devices, systems, and methods for retrievingobjects within a patient.

BACKGROUND

Retrieval devices are often used to remove organic material (e.g., bloodclots, tissue, and biological concretions such as urinary, biliary, andpancreatic stones) and inorganic material (e.g., components of a medicaldevice or other foreign matter), which may obstruct or otherwise bepresent within a patient's body cavities or passages. For example,concretions can develop in certain parts of the body, such as in thekidneys, pancreas, ureter, and gallbladder. Minimally invasive medicalprocedures are used to remove these concretions through naturalorifices, or through an incision, such as during a percutaneousnephrolithotomy (“PNCL”) procedure. Retrieval devices are also used inlithotripsy and ureteroscopy procedures to treat urinary calculi (e.g.,kidney stones) in the ureter of a patient.

Ureteroscopy, for example, may be performed to diagnose and treaturinary tract diseases and ureteral strictures. A ureteroscope may beinserted retrograde through the urinary tract such that diagnosis andtreatment of urinary tract abnormalities may be performed. Currentflexible ureteroscopes require two hands to control the ureteroscope.Usually, the dominant hand will hold the handle of the ureteroscopewhile the non-dominant hand holds the distal portion of the ureteroscopeas it enters the urethral meatus. If the medical professional determinesthere is a need to insert a tool such as a basket, grasper, or forcepsthrough the working channel of the scope, he or she is left to eitherremove the non-dominant hand from the urinary meatus or instruct anassistant to hold the tool handle.

Removing their hand from the urinary meatus, however, removes themedical professional's ability to control the depth of the scope'sinsertion into the urinary meatus. On the other hand, if the medicalprofessional opts to instruct an assistant to control the medical tool,for example, a basket, communication between the medical professionaland assistant must be exact and clear, otherwise, the assistant may berequired to perform multiple attempts at grasping a stone or othermaterial before successfully capturing the stone or other materialwithin the basket. Multiple attempts frequently result in damagedbaskets, increased risk of damage to the patient's surrounding tissue,and increased time of procedure, among others.

In addition, conventional ureteroscopes are designed to be held in thevertical or upright position which necessitates that the medicalprofessional tightly flex his or her arm at the elbow to bring theirforearm parallel to their body and bend their wrist outward to grasp theureteroscope. Distal tip scope deflection may be achieved via anactuator on the proximal end of the scope by the medical professional'sindex finger or thumb. As the medical professional rotates theureteroscope, he or she may experience wrist angulation resulting inpainful symptoms similar those of carpal tunnel. Holding theureteroscope in such an upright position may also interfere with themedical professional's intuitive connection between the motion of theirhand, and the resultant motion of a distal tip of the ureteroscope. Italso precludes them from controlling the depth and rotation of anyinstrument inserted into the ureteroscope and the depth of the scope atthe same time. End deflection and scope rotation is controlled by thedominant hand. The assistant manages the mechanical actuation of theinstrument (opening and closing of graspers, baskets, scissors, loops,etc.).

The systems and methods of the current disclosure may rectify some ofthe deficiencies described above.

SUMMARY

Examples of the present disclosure relate to, among other things,medical retrieval systems and related methods of use. Each of theexamples disclosed herein may include one or more of the featuresdescribed in connection with any of the other disclosed examples.

In one example, a medical device may include a stabilizer configured tobe coupled to a port of an insertion device. The medical device mayfurther include a shaft configured for telescopic translation within thestabilizer and a grip coupled to the shaft. Further, the medical devicemay include an actuator coupled to the grip. The actuator may be axiallymoveable relative to the grip so as to selectively actuate a distalassembly of the medical device.

Examples of the medical device may additionally and/or alternativelyinclude one or more of the following features: the stabilizer mayinclude at least one longitudinally extending slot; the shaft mayinclude at least one protrusion configured to be received within the atleast one longitudinally extending slot; the shaft may be coupled to thestabilizer in a snap-fit arrangement; the stabilizer may include alongitudinally extending opening configured to receive a longitudinallyextending extension of the shaft; the shaft may include at least oneflex arm; the shaft may include at least two flex arms; the actuator mayinclude at least one arm, wherein the arm may have an external surfaceconfigured to matingly cooperate with an internal surface of the grip;the actuator may include at least two arms, wherein each of the at leasttwo arms may have an external surface configured to matingly cooperatewith an internal surface of the grip; the stabilizer may be configuredto be rotatably coupled to an insertion device; a coupler which may befixedly coupled to the stabilizer and removably coupled to the insertiondevice; the shaft may be configured to be selectively prevented fromaxially moving relative to the stabilizer; the actuator may include araised finger or thumb rest; a cross-sectional shape of the shaft may beU-shaped; and an exterior surface of the shaft may be configured to bematingly received within an interior surface of the stabilizer.

In another example, a system may include an insertion device. Theinsertion device may include a tubular member extending along alongitudinal axis. The tubular member may include a deflectable distalportion. The insertion device may also include a pistol-grip handlecoupled to the tubular member. The pistol-grip handle may include a portconfigured to receive a medical device. The system may further include amedical device including a distal assembly and a proximal handle. Theproximal handle may include a stabilizer configured for coupling withthe port, a shaft telescopically coupled to the stabilizer, and anactuator configured to manipulate the distal assembly.

Examples of the system may additionally and/or alternatively include oneor more of the following features: the tubular member may furtherinclude a proximal portion coupled to the pistol-grip handle and amedial portion positioned between the proximal portion and thedeflectable distal portion, wherein the proximal portion is more rigidthan the medial portion and the deflectable distal portion, and whereinthe medial portion is more rigid than the deflectable distal portion;the proximal portion and the medial portion may extend along alongitudinal axis of the tubular member; the insertion device mayfurther include an actuator operatively coupled to the deflectabledistal portion, wherein distal advancement of the actuator may causedeflection of the deflectable distal portion in a first direction, andwherein proximal retraction of the actuator may cause deflection of thedeflectable distal portion in a second direction, opposite of the firstdirection; the port may be a first port and may be positioned along afirst surface of the pistol-grip handle, the insertion device mayfurther include a second port positioned along either a second side ofthe pistol-grip handle opposite the first surface or on a proximalmostend of the pistol-grip handle; the proximal handle may be rotatablycoupled to the port; and the shaft may be coupled to the stabilizer in asnap-fit arrangement.

In a further example, a method may include delivering an insertiondevice into an anatomical opening. The insertion device may include atubular member extending along a longitudinal axis and having adeflectable distal portion. The insertion device may further include aport coupled to a medical device having a stabilizer and a shafttelescopically coupled to the stabilizer. The method may further includemanipulating the deflectable distal portion. The method may also includedistally advancing the shaft relative to the stabilizer and actuating adistal assembly of the medical device.

Examples of the system may additionally and/or alternatively include oneor more of the following features: medical device may be rotatablycoupled to the port; the insertion device may further include anactuator operatively coupled to the deflectable distal portion and themethod may further include at least one of distally advancing theactuator to cause deflection of the deflectable distal portion in afirst direction, and proximally retracting the actuator to causedeflection of the deflectable distal portion in a second direction,opposite of the first direction; and snap-fit connecting the stabilizerto the shaft.

It may be understood that both the foregoing general description and thefollowing detailed description are exemplary and explanatory only andare not restrictive of the disclosure, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate examples of the presentdisclosure and together with the description, serve to explain theprinciples of the disclosure.

FIG. 1 depicts an insertion device according to an example of thedisclosure;

FIG. 2 depicts the insertion device of FIG. 1 in a bent configuration;

FIG. 3 schematically depicts exemplary imaging and illuminationassemblies of the insertion device of FIG. 1;

FIG. 4 depicts an insertion device according to an additional example;

FIG. 5 depicts an insertion device according to yet another example;

FIG. 6 depicts an insertion device according to yet another example;

FIG. 7 depicts an insertion device according to yet another example;

FIG. 8 depicts the insertion device of FIG. 1 coupled with an exemplarymedical device handle;

FIG. 9 is an isometric view of the exemplary medical device handle ofFIG. 8;

FIG. 10 depicts an exemplary stabilizer of the medical device handle ofFIG. 8;

FIG. 11 depicts an exemplary grip and telescopic shaft of the medicaldevice handle of FIG. 8;

FIG. 12 depicts an exemplary actuator of the medical device handle ofFIG. 8;

FIG. 13 depicts an additional exemplary actuator of a medical devicehandle;

FIG. 14 depicts another exemplary actuator of a medical device handle;

FIG. 15 depicts a further exemplary actuator of a medical device handle;

FIG. 16 depicts an additional exemplary actuator of a medical device;

FIGS. 17A-17C illustrate various views of another exemplary actuator ofa medical device handle;

FIG. 18 illustrates a further exemplary actuator of a medical devicehandle;

FIG. 19 illustrates an additional exemplary actuator of a medicaldevice;

FIG. 20 depicts an exemplary method of use of the insertion devices ofFIGS. 1-7 and the medical device handles of FIGS. 8-19;

FIGS. 21A and 21B depict an exemplary reversing mechanism of theinsertion device of FIG. 1; and

FIGS. 22A and 22B depict an exemplary rotational water-tight couplingfor use with any of the insertion devices of FIGS. 1-7 and the medicaldevice handles of FIGS. 8-19.

DETAILED DESCRIPTION Overview

Examples of the present disclosure relate to a medical system fordiagnosing and/or treating internal areas of a subject's body. Themedical system may include a medical device and an insertion device forfacilitating ergonomic manipulation and intuitive control by a medicalprofessional during a procedure.

Detailed Examples

Reference will now be made in detail to examples of the presentdisclosure described above and illustrated in the accompanying drawings.Wherever possible, the same reference numbers will be used throughoutthe drawings to refer to the same or like parts.

The terms “proximal” and “distal” are used herein to refer to therelative positions of the components of an exemplary medical device.When used herein, “proximal” refers to a position relatively closer tothe exterior of the body or closer to a medical professional using themedical device or insertion device. In contrast, “distal” refers to aposition relatively further away from the medical professional using themedical device or insertion device, or closer to the interior of thebody.

FIG. 1 shows an exemplary scope and/or insertion device 10. Insertiondevice 10 may include any device configured to allow a user to performmedical diagnoses and/or treatments on a subject. For example, insertiondevice 10 may include any device configured to allow a user to accessand view internal areas of a subject's body. Additionally oralternatively, insertion device 10 may include any device configured todeliver medical instruments, such as, for example, biopsy forceps,graspers, baskets, snares, probes, scissors, retrieval devices, lasers,and/or other tools, into a subject's body. Insertion device 10 may beinserted into a variety of body openings, lumens, and/or cavities. Forexample, insertion device 10 may be inserted into any portion of aurinary tract, such as a ureter, a gastrointestinal lumen, such as anesophagus, a vascular lumen, and/or an airway.

According to aspects of the present disclosure, insertion device 10 maybe a ureteroscope. In some contemplated examples, insertion device 10may be a sterile, single-use, and disposable ureteroscope.Alternatively, insertion device 10 may be a multiple-use, non-disposableureteroscope. Other types of devices, however, may be substituted forthe ureteroscope, including, as examples, an endoscope, a hysteroscope,a uteroscope, a bronchoscope, a cystoscope, and similar devices. Suchdevices may be single-use and disposable, or multiple-use andnon-disposable.

Insertion device 10 may include a handle assembly 12. Handle assembly 12may include a handle housing 14. Handle housing 14 may include a firstportion 16 and a second portion 18. As shown in FIG. 1, the firstportion 16 may extend along a longitudinal axis A of the insertiondevice 10, while the second portion 16 may extend at an angle B withrespect to longitudinal axis A. For example, in some examples, angle Bmay be about 45°. In other examples, angle B may be between about 0° and90°, between about 20° and 70°, or between about 35° and 55°. It isunderstood that the terms “about,” “substantially,” and “approximately,”as used in this disclosure, include a range of plus or minus 5%.

The angled configuration of the handle assembly 12 provides numerousbenefits. For example, since a medical professional is able to hold thehandle assembly 12 in line with their forearm in a natural position(e.g., across their waist), the handle assembly 12 decreases carpaltunnel strain. Additionally, the pistol-like grip of handle assembly 12enables an ergonomic grasping of insertion device 10 making manipulationof the insertion device increasingly comfortable and user-friendly bykeeping the medical professional's wrist in line with longitudinal axisA of insertion device 10 during rotation and other manipulation ofinsertion device 10. The angled or pistol-like grip of handle assembly12 additionally enables greater rotational freedom along longitudinalaxis A as a medical professional can generally rotate his or her armthrough a larger range of motion when held in the natural position withtheir wrist in line with longitudinal axis A rather than held uprightwith their wrist sharply bent with respect to longitudinal axis A.Finally, the angled or pistol-like grip of the handle assembly 12 may beuniversally grasped by the medical professional's hand, whether or notthey are right-handed or left-handed, thus removing the need forspecialized instruments for different medical professionals.

The handle assembly 12 may be formed in any appropriate manner. Forexample, two half-portions may be joined together by appropriatefasteners, such as, removable fasteners including screws and/or pins, orby non-removable fastening techniques, including heat bonding oradhering with an adhesive. Alternatively, handle assembly 12 may beextruded as a one-piece monolithic construction.

Insertion device 10 may also include a longitudinally extending tubularmember 20 operably connected to handle assembly 12. Tubular member 20may include, for example, a catheter, and may be configured to be atleast partially inserted into a subject's body and navigated to aninternal area therein. Tubular member 20 may be semi-rigid. For example,tubular member 20 may include one or more portions that are flexible,while others are substantially rigid. Its flexibility may allow tubularmember 20 to be maneuvered into, through, and out of the subject's body.Tubular member 20 may be configured, for example, to traverse tortuousanatomical lumens of the subject's body.

For example, tubular member 20 may include a proximal portion 22, amedial portion 24, and a distal portion 26. The length of the proximalportion 22 may be approximately 12 to 25 cm long and be about 10 to 18French (6 mm) in diameter; the length of the medial portion 24 may beapproximately 20 to 30 cm long and be about 7 to 8 French (2.3 to 2.7mm) in diameter; and the length of the distal portion 26 may beapproximately 6 cm long and be about 7 to 8 French (2.3 to 2.7 mm) indiameter. It is understood, however, that larger or smaller dimensionsmay be appropriate for some patients and are within the scope of thisdisclosure. The proximal, medial, and distal portions 22, 24, and 26,may have cross-sectional configurations that are substantially uniformalong their lengths, but they may taper distally. In other examples, thecross-sectional shape may vary along their length. For example, in someexamples, proximal portion 22 may have an ovular cross-section shapewhile distal portion 26 and/or medial portion 24 have a circularcross-sectional shape. Other sizes, shapes, and arrangements arecontemplated and within the scope of this disclosure.

Given the increased size (e.g., diameter) of proximal portion 22relative to medial portion 24 and distal portion 26, proximal portion 22may be considered a “rigid” portion and provides sufficient strength andrigidity to permit use within the bladder of a patient and to supportthe entry of the distal portion 26 and medial portion 24 into a ureteror other anatomical passage. Accordingly, proximal portion 22 may addrobustness to insertion device 10 and prevent unintended flexion oftubular member 20 while within one or more of the urethra, prostaticfossa, and bladder neck of a patient.

Meanwhile, the medial portion 24, due to its decreased size (e.g.,diameter) relative to proximal portion 22, and due to its increased size(e.g., diameter) relative to distal portion 26, may be considered a“semi-rigid” portion and provides numerous benefits. First, medialportion 24 may enhance the rotational response or insertion depthresponse of insertion device 10 when a medical professional rotates ordistally advances handle assembly 12, and therefore, tubular member 20.Additionally, medial portion 24 eliminates the need for the medicalprofessional to hold the insertion device 10 with his/her non-dominanthand at the urethral meatus to control insertion device 10 depth,thereby freeing a hand of the medical professional for other purposes.Additionally, due to its semi-rigid construction, medial portion 24 mayenhance durability during a procedure, and/or during sterilization ifreused.

The distal portion 26, due to its decreased size (e.g., diameter)relative to the proximal portion 22 and the medial portion 24, may beconsidered a “flexible” portion and may be manipulated as needed duringa procedure, as will be described in further detail below. Since theinsertion device 10 is designed to be held in line with the longitudinalaxis A of the tubular member 20, the length of distal portion 26 may belargely reduced relative to conventional insertion devices.

Handle assembly 12 may further include an actuator 28 for manipulatingdistal portion 26. For example, actuator 28 may include a ring, button,and/or trigger configured to be proximally retracted and/or distallyadvanced by a finger of the medical professional. The actuator 28 may bemechanically coupled to (e.g., via a push/pull wire and/or cable) orotherwise cooperate (e.g., via an electrical servomotor) with the distalportion 26 of tubular member 20. For example, as shown in FIG. 1,actuator 28 may include a circular hole or opening 30, through which anindex or other finger of a medical professional may be inserted. Uponurging actuator 28 in the distal direction, distal portion 26 may becaused to bend and/or flex in a first direction, as shown in FIG. 2.Upon urging actuator 28 in the proximal direction, distal portion 26 maybe caused to bend and/or flex in a second direction, opposite the firstdirection. In such a manner, distal portion 26 may be moved, angled, orotherwise manipulated in a first and a second direction within a planeso as to direct the distal portion 26 as needed during a procedure. Suchcontrol may aid the medical professional in directing a medical devicepassed through the tubular member 20 of insertion device 10 to aspecific location within a patient.

The distal portion 26 may be operatively coupled to the actuator 28 inany appropriate manner. For example, push/pull wires or otherlongitudinally extending members (not shown) may extend through conduitswhich extend longitudinally through tubular member 20. A proximal end ofthe push/pull wires may be coupled to the actuator 28, while a distalend may be anchored near, on, or within the distal portion 26 such thatmanipulation of the actuator 28 may cause distal portion 26 bend, move,or flex as shown in FIG. 2. For example, moving the actuator in a distaldirection may cause one push/pull wire to be relaxed while anotherpush/pull wire may be tensioned thereby causing the distal portion 26 tobend towards the tensioned push/pull wire, and vice versa. Alternativemechanisms may be used to manipulate distal portion 26 without departingform the scope of this disclosure. In some examples, linkages, rack andpinion arrangements, reversing rack and pinion arrangements,electro-mechanical, and/or electrical components may be used to causedistal portion 26 to bend in either the first or second directions.

In examples in which a reversing rack and pinion arrangement is used, amedical professional may choose whether he or she would like to followthe European standard (e.g., where a downward motion on an actuatorresults in an upward deflection, and vice versa) or U.S. standard (e.g.,where a downward motion on an actuator results in a downward deflection,and vice versa). In such cases, and referring to FIGS. 21A and 21B, arack gear system 300 may be attached to actuator 28 and include amoveable reversing rack gear 310 including an upper rack 310A and alower rack 310B moveably coupled to an actuator rack 320. The rack gearsystem 300 may further include an actuator pinion 330 including a commondrive shaft 340 with a reversing pinion 350. Further, reversing rackgear 310 may be coupled to and/or include a linkage 360 which may becoupled to distal portion 26 via one or more push/pull wires or otherlongitudinally extending members (not shown).

As shown in FIG. 21A, reversing rack gear 310 may be positioned suchthat an adjustment mechanism, such as eccentric cam 370, may adjustwhich of upper rack 310A and lower rack 310B engage with reversingpinion 350. For example, in the position shown in FIG. 21A, eccentriccam 370 is positioned downward so as to urge reversing rack gear 310downward, thereby enabling teeth of upper rack 310A to operably engageteeth of reversing pinion 350 while teeth of lower rack 310B are freefrom engagement with teeth of reversing pinion 350. As shown in FIGS.21A and 21B, reversing rack gear 310 may be spring-loaded or biased(e.g., via one or more springs 380 shown in a compressed configuration)such that when eccentric cam 370 is rotated 180° from the position shownin FIG. 21A, eccentric cam 370 no longer urges reversing rack gear 310downward and springs 380 return towards an uncompressed state therebyurging teeth of lower rack 310B to operably engage teeth of reversingpinion 350 while teeth of upper rack 310A are free from engagement withteeth of reversing pinion 350. Eccentric cam 370 may be adjusted throughany appropriate means, such as, for example, an adjustment wheel orslide actuator on handle assembly 12.

In use, a medical professional may adjust the eccentric cam 370 in adesired orientation, such as, for example, the downward orientationshown in FIG. 21A. Accordingly, reversing rack gear 370 may be urgeddownward such that teeth of upper rack 310A engage with teeth ofreversing pinion 350. In use, the medical professional may causeactuator 28 to move in direction C as depicted by the arrow in FIG. 21A.Actuator 28 may be directly coupled to or monolithically formed withactuator rack 320 such that actuator rack 320 is urged in the samedirection C. As actuator rack 320 is urged in direction C, teeth ofactuator rack 320 may engage teeth of actuator pinion 330 therebyrotating actuator pinion 330 in the counter clockwise direction, asshown in FIG. 21A, which in turn rotates reversing pinion 350 in thesame counter clockwise direction via common drive shaft 340. Asreversing pinion 350 is rotated in the counter clockwise direction,teeth of reversing pinion 350 operably engage and urge (e.g., push)teeth of upper rack 310A in direction D as shown in FIG. 21A which inturn urges distal portion 26 to deflect, bend, and/or flex in a firstdirection (e.g., upward). Additionally, it is understood that ifmovement of actuator 28 is reversed so as to move in a directionopposite of direction C, distal portion 26 will be likewise caused todeflect, bend, and/or flex in a second direction, opposite the firstdirection (e.g., downward).

If, however, the medical professional chooses to follow a differentdeflection standard, he or she may adjust the eccentric cam 370 suchthat eccentric cam 370 no longer urges reversing rack gear 310 downwardand springs 380 return towards an uncompressed state thereby urgingteeth of lower rack 310B to operably engage teeth of reversing pinion350 while teeth of upper rack 310A are free from engagement with teethof reversing pinion 350. In such an arrangement, movement of actuator 28in direction C, may urge actuator rack 320 in the same direction, whichin turn causes actuator pinion 330 and reversing pinion 350 to rotate inthe counter clockwise direction. As reversing pinion 350 is rotated inthe counter clockwise direction, teeth of reversing pinion 350 operablyengage and urge (e.g., pull) teeth of lower rack 310B in direction E asshown in FIG. 21A which in turn urges distal portion 26 to deflect,bend, and/or flex in the second direction (e.g., downward).Additionally, it is understood that if movement of actuator 28 isreversed so as to move in a direction opposite of direction C, distalportion 26 will be likewise caused to deflect, bend, and/or flex in thefirst direction, opposite the second direction (e.g., upward).Accordingly, a medical professional may adjust the direction that distalportion 26 bends in response to actuation via actuator 28. As such, themedical professional may configure the insertion device 10 for usewithin either side of the patient's anatomy (e.g., within eitherkidney); so as to correspond to the US standard; and/or the oppositeconfiguration, referred to as the European standard. The direction ofsuch a reversible rack and pinion arrangements may be switched via oneor more of a cam, screw, spring-loaded switch, or other appropriatecomponent.

Insertion device 10 may further include an imaging assembly 32 shownschematically in FIG. 3. Imaging assembly 32 may include an image sensor34 at a distal end of tubular member 20. For example, image sensor 34may be positioned at a distalmost tip of tubular member 20. Image sensor34 may be at least partially mounted within, or embedded within, thedistal portion 26 of tubular member 20. It is also contemplated thattubular member 20 may have a distal end cap (not shown), and imagesensor 34 may be positioned therein. Image sensor 34 may view an areadistal to the distal end of tubular member 24.

Image sensor 34 may be any suitable type of image sensor configured tocapture images and/or full-motion video images in digital or any othersuitable format. Image sensor 34 may include, for example, a chargedcouple device (“CCD”) or a complementary metal oxide semiconductor(“CMOS”) image sensor. Image sensor 34 may include a pixel count greaterthan 20,000 pixels and less than 80,000 pixels. For example, imagesensor 34 may have a pixel count of about 62,500. Image sensor 34 mayinclude a field of view of at least 80°. For example, image sensor 34may include a field of view of about 110-130°. In some examples, imagesensor 34 may include a field of view of about 120°.

An image sensor connector 36, which may include, for example, one ormore electrical wires or cables extending through an interior of tubularmember 20, may connect the image sensor 34 to a printed circuit board(“PCB”) 38 mounted within an interior of handle assembly 12. PCB 38 maymechanically support and/or electrically connect electronic componentsusing conductive tracks, pads, and other features. PCB 38 may be etchedfrom copper sheets laminated onto a non-conductive substrate. It iscontemplated that electronic components like capacitors, resistors, oractive devices, may be mounted on PCB 38. A signal amplifier (not shown)is one type of active device that may be mounted on PCB 38. Image datacaptured by image sensor 34 may be transmitted through image sensorconnector 36 to PCB 38. The image data may be amplified by the signalamplifier on PCB 38. A signal converter box (not shown) is anotherexample of an active device that may be mounted on PCB 38.

Additionally, an imaging card (not shown) may be mounted on PCB 38. Theimaging card may be configured to drive the capture of image data withimage sensor 34. For example, the imaging card may include appropriatecircuitry and memory to calibrate captured image data from image sensor34, deserialize the captured image data, perform known algorithms, suchas demosaicing, gain control, and white balance, and/or any othersuitable functions, to produce a quality color image. The gain controlmay be implemented by the imaging card by adjusting gains applied to theimage data from image sensor 34.

Alternatively, the imaging card may include appropriate circuitry andmemory to calibrate captured image data from image sensor 34, decode ordeserialize the captured image data, and format the data fortransmission to an external computer (not shown). The computer mayperform known algorithms, such as demosaicing, gain control, and whitebalance, and/or any other suitable functions, to produce a quality colorimage. The gain control may be implemented by the computer by adjustinggains applied to the image data from image sensor 34. The imaging cardmay also include isolation circuitry to prevent undesired radiofrequency susceptibility, emissions and interference, as well asundesired leakage currents in the event of an electrical failure. It isunderstood that additional or alternative devices and/or components maybe mounted on PCB 38.

Insertion device 10 may also include an illumination assembly 40. Asshown in FIG. 3, illumination assembly 40 may include an illuminationunit 42, such as a light-emitting diode (“LED”), an illumination card orcircuit board (not shown), at least one illumination fiber 44, and aheat sink (not shown). LED 42 may be mounted on PCB 38 in the interiorof handle assembly 12. LED 42 may be mounted on conductive tracks orpads on PCB 38. LED 42 may emit light upon receipt of an appropriatepower supply. The power supply may come from an external source such as,for example, a computer, a battery, or a power adapter, via connector46. LED 42 may include, for example, a LUXEON Z LED. Any other suitableLED 42 may be used.

Illumination fiber 44, shown in FIG. 3, may be coupled at a proximal endto LED 42, and at a distal end to the distal end of tubular member 20.Illumination fiber 44 may transmit the light emitted by LED 42 to thedistal end of tubular member 20, where the light may be emitted from thedistal tip of illumination fiber 44 to areas around the distal end oftubular member 20. For example, illumination fiber 44 may direct lightemitted by LED 42 towards a tissue specimen and or stone “S”.Illumination fiber 44 may include an optical fiber made of plastic,glass, or any other suitable light transmissive material.

The Illumination card (not shown) may help drive and/or controloperation of LED 42. For example, the illumination card may help controlthe light output of LED 42. It is contemplated that one or moreactuators or buttons (not shown) may be disposed on handle assembly 12,for controlling operation of LED 42. Additionally or alternatively, oneor more actuators or buttons may be disposed externally on a computer,for controlling operation of LED 42. In one example, gain control forimaging may be implemented by adjusting the intensity of LED 42, andadjusting the gains applied to the signals by image sensor 34. That gaincontrol may be implemented by a computer, an imaging card, andillumination card, and/or electronic components on PCB 38.

LED 42 may generate heat when activated. The heat may be dissipated fromLED 42 by one or more heat sinks (not shown). Such heat sinks may bemounted on PCB 38 using any suitable attachment. For example, a heatsink may be fastened to PCB 38 by screws and pins, and/or by fasteningtechniques, such as heat bonding and adhesive bonding. When mounted onPCB 38, a bottom surface of the heat sink may contact one or moresurfaces of LED 42. Heat generated by LED 42 may transfer into the heatsink, and the heat sink may dissipate the heat. Heat sinks may remainout of contact with handle housing 14. This may ensure that heatdissipated from such a heat sink may not directly heat a portion ofhandle housing 14, thereby possibly damaging handle housing 14 or makingit uncomfortable for a user to grip handle housing 14.

Referring back to FIGS. 1 and 2, handle assembly 12 may also includeports 50 and 52. Ports 50 and 52 may provide access to one or morechannels (not shown) extending through tubular member 20. For example,port 52 may provide access for one or more medical devices into one ormore channels extending through tubular member 20 and out the distalportion 26 of tubular member 20, as will be described in further detailbelow. Additionally or alternatively, port 50 may provide access intoone or more working channels for delivering a suitable fluid, such as aliquid or gas, for irrigation and insufflation purposes, respectively,to and out of the distal portion 26 of tubular member 20. It is alsocontemplated that port 50 may be in fluid communication with one or moreworking channels for withdrawing material from tubular member 20 and/oran area near the distal portion 26 of tubular member 20, using suction.

As shown in FIGS. 1, 2, and 4-6, port 52 is reinforced. For example,port 52 may be reinforced with flange 54. Flange 54 may securely fixport 52 relative to handle assembly 12 so as to avoid inadvertentmovement between handle assembly 12 and port 52. Accordingly, flange 54may be configured to prevent misalignment of medical devices insertedinto and through port 52 relative to handle assembly 12. Flange 54 maybe coupled to handle assembly 12 and port 52 though any appropriatemeans. For example, flange 54 may be securely attached to handleassembly 12 and port 52 through mechanical fasteners (e.g., screws,pins, threaded connectors, etc.), adhesives, heat bonding, welding, andsimilar techniques. Alternatively, flange 54 may be monolithicallyformed with handle assembly 12 and/or port 52 such that it is aone-piece construction.

In some examples, electrical connectors such as image sensor connector36, and/or connector 46 may extend through or alongside port 50 forcoupling to an external component. In such examples, as shown in FIG. 1,port 50 may be positioned underneath handle assembly 12, while port 52may be positioned on a top portion of handle assembly 12. For example,port 50 may be positioned at the 6 o'clock position while port 52 ispositioned at the 12 o'clock position. As such, any fluid supply linesand/or electrical connectors may be out of the way of the medicalprofessional when deploying and/or manipulating a medical device throughport 52, as will be described in further detail below. In other words,because any necessary fluid supply lines and/or electrical connectorsare gathered and positioned on a bottom side of handle assembly 12, themedical professional may insert and manipulate a medical device throughport 52 without entangling or interfering with such fluid supply linesand/or electrical connectors.

In other examples, port 50 may be positioned on a proximal most portionof second portion 18 of handle housing 14 as shown in FIGS. 4 and 5. Insuch arrangements, any necessary fluid supply lines and/or electricalconnectors are gathered and positioned away from port 52, therebyclearing space for a medical professional to insert and manipulate amedical device through port 52 without entangling or interfering withsuch fluid supply lines and/or electrical connectors. Additionally, asshown in FIG. 4, handle assembly 12 may include an additional port suchas port 56 configured for the insertion and removal of additional oralternative tools including, for example, a lithotripter (not shown),positioned near a junction between the first portion 16 and the secondportion 18 of handle housing 14 and thus, away from port 52.

In a further example, as shown in FIG. 6, handle assembly 12 may includea wheel actuator 29 for manipulating distal portion 26, rather thanactuator 28. For example, wheel actuator 29 may include a wheelrotatable via a thumb or finger of the medical professional. The wheelactuator 29 may be mechanically coupled to (e.g., via a push/pull wireand/or cable) or otherwise cooperate (e.g., via an electricalservomotor) with the distal portion 26. Wheel actuator 29 may betextured and/or include one or more serrations, protrusions, and/or thelike to improve a medical professional's grip on wheel actuator 29,thereby enabling improved tactile response of wheel actuator 29. Uponrotating or otherwise urging wheel actuator 29 in a first direction(e.g., clockwise), distal portion 26 may be caused to bend and/or flexin a first direction. Upon rotating or otherwise urging wheel actuator29 in a second direction (e.g., counter clockwise), distal portion 26may be caused to bend and/or flex in a second direction, opposite thefirst direction. In such a manner, distal portion 26 may be moved,angled, or otherwise manipulated in a first and a second directionwithin a plane so as to direct the distal portion 26 as needed during aprocedure. The distal portion 26 may be operatively coupled to the wheelactuator 29 in any appropriate manner (e.g., push/pull wires, rack andpinion arrangements, reversing rack and pinion arrangements,electro-mechanical, and/or electrical components). It is understood thatin some insertion device 10 orientations, actuation of wheel actuator 29may result in less stress, strain, and/or effort imparted to or requiredby a medical professional actuating distal portion 26.

Additionally, as shown in FIG. 6, port 52 may provide access to one ormore channels (not shown) extending through tubular member 20 to enableinsertion of one or more medical devices therethrough, as discussedabove. Additionally or alternatively, port 50 may provide access intoone or more working channels for delivering a suitable fluid, such as aliquid or gas, for irrigation and insufflation purposes, respectively,to and out of the distal portion 26 of tubular member 20. It is alsocontemplated that port 50 may be in fluid communication with one or moreworking channels for withdrawing material from tubular member 20 and/oran area near the distal portion 26 of tubular member 20, using suction.In some arrangements, port 50 may further enable insertion of a secondmedical device (e.g., a laser fiber, lithotripter, etc.) therethrough.In such a manner, ports 52 and 50 may facilitate insertion of one ormore medical devices and/or suitable fluids therethrough. In somearrangements, however, only a single port, e.g., port 52 may be locatedalong the 12 o'clock position, while port 50 may either be omitted or belocated at either the 6 o'clock position or along the proximal mostportion of second portion 18 of handle housing 14 as shown in FIGS. 1,4, and 5. In such a manner, any fluid supply lines and/or electricalconnectors may be out of the way of the medical professional whendeploying and/or manipulating a medical device through port 52.

Furthermore, a port 53 may be positioned on a proximal most portion ofsecond portion 18 of handle housing 14 as shown in FIG. 6. Port 53 maybe configured to route an integrated single cable, including electricalconnectors such as image sensor connector 36, and/or connector 46 (FIG.3), and a fluid line, for coupling to an external component includingpower source and fluid management system (not shown). Such an externalcomponent, having an integrated fluid management system associatedtherewith, may be configured to provide irrigation to distal end 26 ofinsertion device 10 and/or regulate fluid flow and pressure to minimizethe risk of over pressurization (which may result inpyelovenous/pyelolymphatic backflow of urine and/or forniceal rupture).Such an external component may additionally include a button, knob,slide, or other such actuator (not shown) which, upon activation by themedical professional, may be caused to increase the flow (e.g., the flowrate and/or pressure) of fluid being delivered to distal end 26 ofinsertion device 10. Accordingly, the external component may enable “ondemand” increase in fluid so as to clear a bloody, or otherwise obscuredor obstructed field of view.

In another arrangement, however, port 53 may include a first portportion 53A and a second port portion 53B, as shown in FIG. 7. Forexample, first port portion 53A may be configured to route electricalconnectors such as image sensor connector 36 and/or connector 46 forcoupling to an external component, while second port portion 53B may beconfigured to route any necessary fluid supply lines to the same or adifferent external component. That is, rather than an integrated singlecable as described above in connection with FIG. 6, first port portion53A and second port portion 53B may define separate and/or distinctports to deliver one or more electrical connectors and/or fluid supplylines to one or more external components.

Additionally, as shown in FIG. 7, first portion 16 and second portion 18of handle assembly 12 may be arranged such that second portion 18 isangled along a less steep or less dramatic angle, relative to thearrangement shown in FIGS. 1, 2, 4, and 5. That is, second portion 18may extend at an angle F relative to longitudinal axis A. For example,in some examples, angle F may be about 15°. In other examples, angle Bmay be between about 0° and 30°, between about 10° and 25°, or betweenabout 12° and 17°. The reduced angle F may facilitate gripping insertiondevice 10 along any radial orientation about longitudinal axis A,thereby enabling easier manipulation of insertion device 10 by themedical professional.

As shown in FIG. 8, a medical device having a handle 60 may be coupledto insertion device 10 via port 52. For example, the medical device mayinclude biopsy forceps, graspers, baskets, snares, probes, scissors,retrieval devices, lasers, and/or other tools. The medical device, maybe routed through port 52, through a working channel of tubular member20, and distally of distal portion 26 such that a distal portion of themedical tool may be configured to perform a procedure within the body ofa patient. By way of example only, the medical device will be describedin reference to a basket hereafter. It is to be understood, however, thehandle 60 may be applicable to any medical device configured forinsertion through a working channel of insertion device 10.

As shown in FIGS. 8 and 9, handle 60 may include a stabilizer 62, atelescopic shaft 64, a grip 66, and an actuator 68. Handle 60 may coupleto port 52 via coupler 70. For example, coupler 70 may be fixedlyattached or monolithically formed with stabilizer 62 and may beconfigured to attach over or be inserted into port 52 thereby joininghandle 60 to insertion device 10. Coupler 70 may be water-tight androtatably coupled to port 52 such that handle 60 may be rotated relativeto port 52 and thereby insertion device 10. Rotation of the handle 60may cause likewise rotation of a distal end of a medical device, therebyproviding an additional degree of freedom to a medical professionalduring a procedure. For example, rotating handle 60 may rotate a basket,thereby allowing the medical professional to arrange or position thebasket to collect a stone or other material during a procedure. Thecoupler 70 may be a standard luer lock screw on adapter.

Stabilizer 62, as shown in FIG. 10, may be a tubular member having aninternal surface 72 with a diameter sized and configured to matinglyreceive telescopic shaft 64. An end 74 of stabilizer 62 opposite coupler70 may define an opening configured to receive an end 76 (FIG. 11) oftelescopic shaft 64. Additionally, stabilizer 62 may include an opening,slot, or passage 78 along an upper surface thereof. Passage 78 may besized and configured to receive a longitudinally extending extension 80(FIG. 11) of telescopic shaft 64. For example, extension 80 may bereceived within passage 78 so as to ensure proper alignment betweenstabilizer 62 and telescopic shaft 64. Accordingly, when assembled (FIG.9) extension 80 resides within passage 78 to prevent inadvertentmisalignment between telescopic shaft 64 and stabilizer 62.Additionally, stabilizer 62 may include a lock or similar member (notshown) configured to prevent inadvertent axial movement of telescopicshaft 64 relative to stabilizer 62. Such a lock may include a pushbutton or similar mechanical construction which may be released by themedical professional when so desired.

In addition to passage 78, stabilizer 62 may include one or more slots82. For example, as shown in FIG. 10, stabilizer 62 may include twoslots 82 positioned on opposite sides of stabilizer 62 and approximately90° from passage 78. In other arrangements fewer or more slots 82 may beprovided through stabilizer in any appropriate arrangement. Each slot 82may be configured to cooperate with a post, flange, or protrusion 84 oftelescopic shaft 64. For example, each slot 82 may be configured toreceive a corresponding protrusion 84 such that protrusion 84 may bemoved along and within slot 82. In such a manner, telescopic shaft 64may be moved axially relative to stabilizer 64, as will be described infurther detail below. It is understood that in some examples, the size,shape, and/or arrangement of protrusions may be varied. For example, afirst protrusion 84 may have a first shape and/or size, while a secondprotrusion 84 may have a second shape and/or size different from thefirst shape and/or size. As such, telescopic shaft 64 may be coupled tostabilizer in only a single arrangement, thereby preventing inadvertentassembly errors.

As shown in FIG. 11, telescopic shaft 64 may be coupled to grip 66. Forexample, telescopic shaft 64 may be secured to grip via any appropriatemechanical fastener (e.g., screws, pins, and/or threaded connectors) orcoupling techniques such as, for example, welding, heat bonding, and/oradhesives. Alternatively, grip 66 may be monolithically formed withtelescopic shaft 64 such that telescopic shaft 64 and grip 66 are aone-piece construction. For example, telescopic shaft 64 and grip 66 maybe extruded as a one-piece construction.

Telescopic shaft 64 may be a hollow generally U-shaped member having oneor more flex arms 86. For example, as shown in FIG. 11, each flex arm 86may include a narrow or thin cantilevered member including at least oneprotrusion 84 thereon. As shown, a width W₁ of each flex arm 86 may besmaller than a width W₂ of surrounding portions of telescopic shaft 64.Accordingly, each flex arm 86 is more flexible than surrounding portionsof telescopic shaft 64. As such, each flex arm 86 may bend and itsassociated protrusion 84 may be received within a corresponding slot 82on stabilizer 62 in a snap-fit arrangement. Once positioned within aslot 82, each protrusion 84 may move along and within track 82 as willbe described in further detail below.

Grip 66 may include one or more baffles 88 configured to aid a medicalprofessional with securely grasping grip 66. Any number and arrangementof baffles 88 may be disposed on grip 66. Additionally, grip 66 mayinclude a slide recess 90 as shown in FIG. 11. Slide recess 90 may be alongitudinally extending opening extending through grip 66 andconfigured to matingly receive actuator 68 moveably therein. Forexample, actuator 68, as shown in FIG. 12, may include a thumb or fingerrest 92 and arms 94. In use, a medical professional may urge rest 92distally along slide recess 90 so as to actuate the medical device(e.g., open a basket). As such, a distal end 98 of actuator 68 may becoupled to the medical device such that movement of the actuator 68causes likewise movement of the medical device. For example, the medicaldevice may include a sheath (not shown) and drive wire (not shown)including a distal assembly (e.g., basket) (not shown) on a distal endthereof. The distal end 98 of actuator 68 may be fixedly coupled to thedrive wire while the sheath may be fixedly coupled to telescopic shaft64. Accordingly, distal movement of actuator 68 may urge the drive wireand distal assembly of the medical device relative to the sheath of themedical device, thereby expanding or opening the distal assembly of themedical device. Arms 94 may be configured to be matingly cooperate withand be received within an opening 96 of grip 66 as shown in FIG. 9. Forexample, an external surface of each arm 94 may be configured to slidealong an internal surface of opening 96. As such, arms 94 maintainactuator 68 within grip 66 and while allowing relative movement betweenactuator 68 and grip 66 so as to actuate the medical device. It isunderstood that other arrangements of arms 94 may be used such as, forexample, a single semi-circular arm or other configuration may be usedwithout departing from the scope of this disclosure.

While FIGS. 8, 9, and 12 depict a longitudinally slideable actuator 68,it is understood that additional or alternative actuation mechanisms maybe used without departing from the scope of this disclosure. Forexample, a roller wheel 100 (FIG. 13) and/or a toggle lever 102 (FIG.14) may be used so as to actuate the medical device (e.g., open abasket). As such, actuator 100 or 102 may be coupled to the medicaldevice such that movement of the actuator 100 or 102 causes likewisemovement of the medical device. For example, the medical device mayinclude a sheath (not shown) and drive wire (not shown) including adistal assembly (e.g., basket) (not shown) on a distal end thereof. Theactuator 100 or 102 may be fixedly coupled to the drive wire while thesheath may be fixedly coupled to telescopic shaft 64. Accordingly,movement of actuator 100 or 102 may urge the drive wire and distalassembly of the medical device relative to the sheath of the medicaldevice, thereby expanding or opening the distal assembly of the medicaldevice.

As noted above, FIG. 13 and FIG. 14 illustrate a roller wheel 100 and atoggle lever 102, respectively, along a distal portion of grip 66.However, the disclosure is not so limited. For example, roller wheel 100and toggle lever 102 may each be positioned along a proximal end of grip66, as shown in FIGS. 15 and 16, respectively. In such an arrangement,each of handles 60 of FIGS. 15 and 16 may also be readily used withconventional insertion devices such as, for example, flexibleendoscopes, flexible cystoscopes, flexible gastroscopes, flexibleduodenoscopes such as Boston Scientific Spyglass II, flexiblecolonoscopes, or other flexible scopes used in medicine and otherfields, without inducing additional ergonomic strain. For example, asdiscussed above, flexible scopes are designed to be held in the verticalor upright position which necessitates that the medical professionaltightly flex his or her arm at the elbow to bring their forearm parallelto their body and bend their wrist outward to grasp the conventionalinsertion device with his or her dominate hand. Placement of rollerwheel 100 and/or toggle lever 102 along the proximal end of grip 66enables the medical professional to orient his non-dominate hand and armin a similar fashion as the upright dominate arm and hand to hold handle60. That is, both arms of a medical professional may be aligned in ageneral parallel orientation so as to accommodate ergonomic and anatomicconsiderations.

FIGS. 17A-17C illustrate another exemplary actuator of a medical devicehandle 60 having a syringe configuration. Similar to handle 60 describedabove in connection with FIG. 8, handle 60 of the example shown in FIG.17A includes a stabilizer 62 and a telescopic shaft 64. Rather than grip66 and actuator 68, however, handle 60 of FIG. 17A includes a tube 104including a finger grip 108. As shown, tube 104 may be configured toreceive a plunger 106, defining a thumb or finger ring 110, movablytherein. That is, plunger 106 may be axially translatable within tube104. For example, ring 110 may include a loop and/or a circular hole oropening 112, through which a thumb or finger of a medical professionalmay be inserted. Upon urging ring 110 distally, an end-effector assembly(e.g., basket) of the medical device may extend distally of a sheath(not shown) of the medical device. Once distal of the sheath, theend-effector assembly may radially expand to open.

FIG. 17B illustrates an exploded view of the handle 60 of FIG. 17A. Asshown, plunger 106 may have a varied cross-section. That is, a firstportion 106A of plunger 106 may have a first cross-sectional shape(e.g., cross or x-shape), a second portion 106B may have a generallycircular cross-sectional shape, and a third portion 106C may have agenerally circular cross-sectional shape having a smaller diameter thanthe second portion 106B. As shown, an end-effector assembly (e.g.,basket) of the medical device may be coupled to plunger 106 via anelongate wire, shaft, tube, or other such member, 114. Wire 114 mayextend proximally from the end effector (not shown) through and/or alongstabilizer 62, through and/or along telescopic shaft 64, through and/oralong tube 104, through and/or along a lock or vise 116, into plunger106 and through a slit or hole 118 extending along at least a portion(e.g., second portion 106B and third portion 106C) of plunger 106. Thatis, a proximal end of wire 114 may be passed from a location withinplunger 106, and through slit 118. To secure wire 114 (and the endeffector of the medical device) relative to plunger 106, vise 116 may berotatably coupled, moved over, positioned about, or otherwise arrangedalong third portion 106C. As such, vise 116 may compress third portion106C and slit 118 so as to pinch or otherwise retain wire 114 relativeto plunger 106. Further, the sheath (not shown) of the medical devicemay be fixedly coupled to telescopic shaft 64. In such a manner, axialtranslation of plunger 106 relative to tube 104 may result in axialdisplacement of the end effector of the medical device, relative to thesheath (not shown) of the medical device, thereby enabling the endeffector to deploy and/or expand.

In order to prevent the medical professional from inadvertently pullingplunger 106 out of tube 104, a proximal end of shaft may include one ormore detents 120, as shown in FIG. 17C. Detents 120 may define a flangeor abutment surface 122 which may limit proximal retraction of plunger106 once inserted within tube 104. That is, detents 120 may flexradially outwardly from a central longitudinal axis of tube 104 suchthat plunger 106 and vise 116 may be inserted therein. However, abutmentsurface 122 of detents 120 may cooperate with a proximal end of secondportion 106B of plunger 106 to limit or interfere with proximalretraction thereof. In such a manner, plunger 106 may be retrained withtube 104. In other arrangements, however, tube 104 may not includedetents 120. Rather, after insertion of plunger 106 within tube 104, acap (not shown) may be coupled (e.g., screwed) onto a proximal end oftube 104. In such a manner, plunger 106 and tube 104 may be selectivelyuncoupled from one another to enable cleaning, repair, or when necessaryto address an oversized stone or other material.

Alternative arrangements of finger grip 108 are also contemplated. Forexample, as shown in FIG. 18, finger grip 108 may be replaced by adouble finger ring 124 arrangement. That is, a first finger ring 126 anda second finger ring 128 may be symmetrically arranged along tube 104.Accordingly, the medical professional may place each of his or her indexand middle fingers through one of the first and second finger rings 126and 128, and his or her thumb or another finger through the finger ring110. In so doing, a medical professional may manipulate his or her handso as to advance and retract double finger ring 124 arrangement, andtherefore tube 104, relative to finger ring 110, and therefore plunger106 so as to advance and retract the end effector of a medical device.Further, in another example, as shown in FIG. 19, an alternativearrangement may include a single finger ring 130 coupled to tube 104while a double finger ring 130 arrangement, including first and secondfinger rings 134 and 136, may be coupled to plunger 106. That is,plunger 106 may be coupled to second finger ring 136 which may be inturn coupled to a first finger ring 134. Accordingly, the medicalprofessional may place each of his or her index and middle fingersthrough one of the first and second finger rings 134 and 136, and his orher thumb or another finger through the finger ring 130. In so doing, amedical professional may manipulate his or her hand so as to advance andretract double finger ring 132 arrangement, and therefore plunger 106,relative to finger ring 130, and therefore plunger tube 104 so as toadvance and retract the end effector of a medical device.

As noted above, and as shown in FIGS. 8 and 9, handle 60 may couple toport 52 of insertion device 10 via coupler 70. Additionally, however,any of the above disclosed medical device handles 60 may include coupler70 coupling telescopic shaft 64 and grip 66. In either arrangement, suchcouplers 70 may be rotatable and water tight. Further, an exemplarycoupler 170 may be constructed as shown in FIGS. 22A and 22B. Forexample, as shown in FIGS. 22A and 22B, coupler 170 may include a gasketsuch as, for example, an O-ring 172. O-ring 172 may enable a water tightseal in medical device handle 60. Additionally, coupler 170 may includea rotatable male luer lock fitting 174 configured for coupling with acorrespondingly shaped female luer lock fitting (not shown). That is, asshown in FIG. 22B, for example, male luer lock fitting 174, along withO-ring 172, may be positioned, received, and/or retained within aportion of stabilizer 62. For example, stabilizer 62 may define a pocket176, recesses, groove, or other such structure configured to receiveO-ring 172 and male luer lock fitting 174 therein. As shown, pocket 176may include a first surface 178 and a second surface 180 extending alonga longitudinal axis of stabilizer 62. First and second surfaces 178 and180 may be spaced longitudinally so as to limit sliding of O-ring 172and male luer lock fitting 174 along the longitudinal axis of stabilizer62, while still enabling sufficient space to allow male luer lockfitting 174 to freely rotate therein. As shown, male luer lock fitting174 may have an inner coupling port 182 and an outer internally threadedextension 184. A female luer lock fitting (not shown) may be coupled tomale luer lock fitting 174 between coupling port 182 and extension 184,as is known in the art. Accordingly, coupling 170 may enable a watertight rotatable connection between two components, such as, for example,between stabilizer 62 and port 52 (or any other such port), and/orbetween telescopic shaft 64 and grip 66.

An exemplary method 200 of use will now be described with reference toFIG. 20. First, a medical professional may insert the insertion device10 into the body of a patient at step 210. For example, a distal end ofthe insertion device 10 may be inserted through the urethral meatus ofthe ureter. Once inserted, the medical professional may optionallydeflect the distal portion 26 of insertion device 10 as necessary todirect the distal portion 26 towards an area or object of interestwithin the body of the patient as shown at step 220. As such, themedical professional may rotate the insertion device 10 through adesired angular range of motion and/or manipulate actuator 28 to bend,deflect, or otherwise move distal portion 26 as desired. A medicalprofessional may gauge the proper placement of the distal portion 26 ofthe medical device under the guide of the imaging 32 and illumination 40assemblies described above (FIG. 3).

If the medical professional determines there is a need for the insertionof a medical device, he or she may insert said device through port 52 asstep 230. For example, the medical professional may use one hand, forexample, the dominant hand, to maintain a grasp on the insertion devicewhile using his or her second hand, for example, the non-dominant hand,to position a medical device, for example, a basket, through the port52. As such, the medical professional may attach coupler 70 to port 52,thereby coupling the handle 60 of the medical device and stabilizer 62to insertion device 10. It is understood that in some examples,stabilizer 62 and the medical device may be coupled to port 52 prior toinsertion of the insertion device 10 into the body of the patient.

As noted above, stabilizer 62 may include a lock configured to preventaccidental axial movement of telescopic shaft 64 relative to stabilizer62. Accordingly, when the medical professional determines the need todeploy the medical device, for example, a basket, he or she may unlockthe stabilizer and allow telescopic shaft 64 to move relative tostabilizer 62 at step 240. For example, unlocking stabilizer 62 mayallow telescope shaft 64 to move distally relative to and withinstabilizer 62 such that a distal portion of the basket may extenddistally of distal portion 26 of insertion device 10.

Once the distal portion of the medical device, e.g., basket, is extendeddistally of distal portion 26, a medical professional may actuate thebasket to open so as to be configured to receive an object therein atstep 250. To do so, the medical professional may urge any one or more ofactuator 68, 100, 102, and 110 to cause an end-effector assembly of thebasket to extend distally of a sheath (not shown) of the basket. Oncedistal of the sheath, the end-effector unit may radially expand to openand receive a stone or other material therein. If the medicalprofessional needs to redirect or aim the basket to a differentorientation, he or she may rotate the handle 60, and therebyend-effector so as to re-orient the end-effector as needed at step 260.Once at the desired position, the medical professional may treat thepatient with the medical device by, for example, capturing a stone orother material within the basket at step 270. Once a desired treatmentis completed, a medical professional may withdraw or remove the medicaldevice and/or insertion device 10 at step 280.

The insertion device 10 and medical device handle 60 of the instantdisclosure provide numerous features. For example, the insertion device10 and handle 60 of the medical device may be operated by the dominantand non-dominant hand, or vice versa, respectively, of a single medicalprofessional. Accordingly, the need for precise communication betweenthe medical professional and any assistants is reduced as the entireprocedure may be performed by a single operator. Indeed, as the dominanthand, for example, may remain on the insertion device 10 throughoutoperation, the medical professional may maintain all three degrees offreedom of the insertion device. First, the medical professional mayensure x-axis depth control of the tubular member 20 of the insertiondevice 10 within the body of the patient. Due to the rigid andsemi-rigid nature of the proximal portion 22 and medial portion 24,respectively, the need for the medical professional to hold theinsertion device with his/her non-dominant hand at the urethral meatusto control insertion depth is eliminated. Rather, the robust (e.g.,thick) nature of these portions prevent egress of the tubular member 20back out of the urethra of a patient. Second, the medical professionalmay use a finger or thumb of the dominant hand to push and/or pullactuator 28 to control bending or deflection of the distal portion 28within the y-axis. Additionally, the medical professional may rotate theinsertion device 10 with his or her dominant hand thereby enabling fullz-axis control of insertion device 10. Accordingly, the medicalprofessional is provided with a full range of motion of the insertiondevice 10 with only a single hand, thereby freeing his or her other handfor manipulation of a medical device. Additionally, the timenecessitated by a medical procedure may be reduced since time spentadvising and/or instructing an assistant may be reduced.

Further, since a medical professional is able to hold the angledconfiguration of the handle assembly 12 in line with their forearm in anatural position (e.g., across their waist), the handle assembly 12decreases carpal tunnel strain. Additionally, the pistol-like grip ofhandle assembly 12 enables an ergonomic grasping of insertion device 10making manipulation of the insertion device increasingly comfortable anduser-friendly by keeping the medical professional's wrist in line withlongitudinal axis A of insertion device 10 during rotation and othermanipulation of insertion device 10. The angled or pistol-like grip ofhandle assembly 12 additionally enables greater rotational freedom alonglongitudinal axis A as a medical professional can generally rotate hisor her arm through a larger range of motion when held in the naturalposition with their wrist in line with longitudinal axis A rather thanheld upright with their wrist sharply bent with respect to longitudinalaxis A. Further, the angled or pistol-like grip of the handle assembly12 may be universally grasped by the medical professional's hand,whether or not they are right-handed or left-handed, thus removing theneed for specialized instruments for different medical professionals.Finally, since the insertion device 10 is configured (e.g., viapistol-like grip of handle assembly 12) to be held in the naturalposition with their wrist in line with longitudinal axis A, the movementof the distal portion 26 may be made more intuitive than conventionalinsertion devices by mimicking the pointing and flexing of the medicalprofessional's index finger.

Further, the semi-rigid construction of tubular member 20 provides anumber of additional advantages. Beyond facilitating single hand controlby the medical professional, the tubular member 20 may be greatlyreduced in overall length compared to conventional insertion devices. Assuch, the overall cost of goods required for manufacture may be reduced.Decreased overall length also enables improved rotational responsivenessof a medical device extending through the tubular member 20 and lessbinding or kinking of the medical device since the tubular member 20extends substantially straight along the longitudinal axis A.Additionally, positioning of the port 50, and the optional port 56, awayfrom port 52 may clear space for a medical professional to insert andmanipulate a medical device through port 52 without entangling orinterfering with fluid supply lines, electrical connectors, and/oradditional tools.

Additionally, the handle 60 enables a medical professional to controlmanipulation of the medical device with a single hand, for example, thenon-dominant hand. Indeed, the inclusion of stabilizer 62 allows amedical professional to quickly and easily control the depth ofinsertion of the medical device. Additionally, the medical device may bequickly and easily actuated via actuator 68 and rotation of handle 60such that a single medical professional may operate the medical device.Accordingly, the described insertion device 10 and medical device handle60 provide a medical professional command and control of the aspects ofthe medical system throughout a procedure thus enhancing procedureefficiency and reducing the number of hands/people required forcompletion of the procedure. Additionally, it is understood that thedisclosed medical device handle 60 may be used in conjunction with anyscope and/or insertion device readily available. For example, medicaldevice handle 60 may be used with a conventional scope and/or insertiondevice, such as any flexible, semi-rigid, and/or rigid insertion device.

It is to be understood that any of the various insertion device 10arrangements described herein may be used with any of the describedmedical device handles 60 described herein. Additionally oralternatively, any of the described insertion devices 10 may include anyof the described actuator 28, wheel actuator 29, or other such actuatorsconfigured to deflect distal portion 26. More so, any of the describedinsertion device 10 may include any of ports 50, 52, 53, and/or firstand second port portions 53A and 53B, in any location along insertiondevice 10 so as to facilitate insertion and retraction of one or moremedical devices, and/or routing any necessary fluid supply lines,electrical connectors, and/or integrated fluid and electrical supplylines.

While principles of the present disclosure are described herein withreference to illustrative examples for particular applications, itshould be understood that the disclosure is not limited thereto. Thosehaving ordinary skill in the art and access to the teachings providedherein will recognize additional modifications, applications, examples,and substitution of equivalents all fall within the scope of theexamples described herein. Accordingly, the disclosure is not to beconsidered as limited by the foregoing description.

We claim:
 1. A medical device, comprising: a stabilizer configured to becoupled to a port of an insertion device; a shaft configured fortelescopic translation within the stabilizer; a grip coupled to theshaft; and an actuator coupled to the grip, wherein the actuator isaxially moveable relative to the grip so as to selectively actuate adistal assembly of the medical device.
 2. The medical device of claim 1,wherein the stabilizer includes at least one longitudinally extendingslot.
 3. The medical device of claim 2, wherein the shaft includes atleast one protrusion configured to be received within the at least onelongitudinally extending slot.
 4. The medical device of claim 1, whereinthe shaft is coupled to the stabilizer in a snap-fit arrangement.
 5. Themedical device of claim 1, wherein the stabilizer includes alongitudinally extending opening configured to receive a longitudinallyextending extension of the shaft.
 6. The medical device of claim 1,wherein the shaft includes at least one flex arm.
 7. The medical deviceof claim 1, wherein the actuator includes at least one arm, wherein thearm has an external surface configured to matingly cooperate with aninternal surface of the grip.
 8. The medical device of claim 7, whereinthe actuator includes at least two arms, wherein each of the at leasttwo arms has an external surface configured to matingly cooperate withan internal surface of the grip.
 9. The medical device of claim 1,wherein the stabilizer is configured to be rotatably coupled to aninsertion device.
 10. A system comprising: an insertion device,including: a tubular member extending along a longitudinal axis, thetubular member including a deflectable distal portion; and a pistol-griphandle coupled to the tubular member, the pistol-grip handle including aport configured to receive a medical device; and a medical deviceincluding a distal assembly and a proximal handle, wherein the proximalhandle includes: a stabilizer configured for coupling with the port; ashaft telescopically coupled to the stabilizer, and an actuatorconfigured to manipulate the distal assembly.
 11. The system of claim10, wherein the tubular member further includes a proximal portioncoupled to the pistol-grip handle and a medial portion positionedbetween the proximal portion and the deflectable distal portion, whereinthe proximal portion is more rigid than the medial portion and thedeflectable distal portion, and wherein the medial portion is more rigidthan the deflectable distal portion.
 12. The system of claim 11, whereinthe proximal portion and the medial portion extend along a longitudinalaxis of the tubular member.
 13. The system of claim 10, wherein theinsertion device further includes an actuator operatively coupled to thedeflectable distal portion, wherein distal advancement of the actuatorcauses deflection of the deflectable distal portion in a firstdirection, and wherein proximal retraction of the actuator causesdeflection of the deflectable distal portion in a second direction,opposite of the first direction.
 14. The system of claim 10, wherein theport is a first port and is positioned along a first surface of thepistol-grip handle, the insertion device further including a second portpositioned along either a second surface of the pistol-grip handleopposite the first surface or on a proximalmost end of the pistol-griphandle.
 15. The system of claim 10, wherein the proximal handle isrotatably coupled to the port.
 16. The system of claim 10, wherein theshaft is coupled to the stabilizer in a snap-fit arrangement.
 17. Amethod for using a system, the method including: delivering an insertiondevice into an anatomical opening, the insertion device including atubular member extending along a longitudinal axis and having adeflectable distal portion, wherein the insertion device includes a portcoupled to a medical device having a stabilizer and a shafttelescopically coupled to the stabilizer; manipulating the deflectabledistal portion; distally advancing the shaft relative to the stabilizer;and actuating a distal assembly of the medical device.
 18. The method ofclaim 17, wherein the medical device is rotatably coupled to the port.19. The method of claim 17, wherein the insertion device furtherincludes an actuator operatively coupled to the deflectable distalportion, the method further including at least one of distally advancingthe actuator to cause deflection of the deflectable distal portion in afirst direction, and proximally retracting the actuator to causedeflection of the deflectable distal portion in a second direction,opposite of the first direction.
 20. The method of claim 17, furtherincluding: snap-fit connecting the stabilizer to the shaft.